Oncology: Strategic Biosimulation Services

Over the past eight years, Certara has performed over 140 modeling projects to support oncology drug development. Under the leadership of Dr. Rene Bruno, Certara has pioneered the development of a Tumor Growth Inhibition (TGI) model to leverage Phase II data to predict Phase III overall survival or progression-free survival. In addition, we have applied a range of modeling techniques to address critical decisions from pre-clinical to late stage clinical for antibodies, proteins and small molecules, such as C-QT modeling, metadata analysis, preclinical to Phase 2 PK and TK analysis, and PBPK modeling and simulation.

Number and types of projects:

  • Type - antibodies, fusion proteins, small molecules
  • Disease areas
    • Breast cancer
    • Glioblastoma
    • Melanoma
    • Non-Hodgkin's lymphoma
    • Non-small cell lung cancer
    • Pancreatic cancer
    • Renal cell carcinoma
    • Acute myeloid leukemia
    • Multiple myeloma
    • Urinary bladder cancer
    • Ovarian cancer
    • Prostate cancer
    • Thyroid cancer

Biosimulation technology is a leap forward in bringing safer, more effective medications to cancer patients. Certara Consulting Services can help sponsors optimize dosing, inform drug labels, achieve regulatory compliance, and in some cases, waive clinical trials.